NCT06303960 Cerebellar Deep Brain Stimulation or VNS for Chronic Post-stroke Motor Rehabilitation
| NCT ID | NCT06303960 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Qilu Hospital of Shandong University |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-15 |
| Primary Completion | 2025-06-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2024-03-15 with a primary completion date of 2025-06-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts.In this open-label, randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. Vagus nerve stimulation was also conducted for motor function after ischaemic Stroke.We hypothesized that cerebellar stimulation was superior to vagus stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum.
Eligibility Criteria
Inclusion Criteria: * Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 12-36 months before surgery. * Individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an FM-UE score of ≤42 * Sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the FM-UE elbow flexion, elbow extension or finger mass flexion or extension). Exclusion Criteria: * Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4) * Severe cognitive impairment (Mini Mental State Examination \< 24)
Frequently Asked Questions
Who can join the NCT06303960 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06303960 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06303960 currently recruiting?
Yes, NCT06303960 is actively recruiting participants. Visit ClinicalTrials.gov or contact Qilu Hospital of Shandong University to inquire about joining.
Where is the NCT06303960 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06303960 clinical trial?
NCT06303960 is sponsored by Qilu Hospital of Shandong University. The trial plans to enroll 100 participants.
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